Measles Clinical Trial
Official title:
Partially Randomized, Controlled Phase II Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years
Partially randomized, controlled Phase II study to evaluate safety, immunogenicity and dose response of the measles vaccine MVA mBN85B in healthy children aged 6 months to 6 years.
Open label study to assess the safety and immunogenicity of MVA-mBN85B in healthy vaccine-naive, measles-naive and measles-experienced children. The study is comprised of three groups with 30 children each. Two groups will receive two subcutaneous (s.c.) immunizations 4 weeks (28±3 days) apart of either either 1 x 10E7 TCID50 (Group A) or 1 x 10E8 TCID50 (Group B) MVA mBN85B. The control group (Group C) will receive two s.c. doses (0.5 ml, 1000 TCID50) of Rouvax® (Sanofi-Pasteur) 24 weeks apart. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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